849a - Regulatory Affairs Specialist Ii (Anual)
hace 4 días
Work Shift:DAYWork Schedule:Why Merit?At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.ESSENTIAL FUNCTIONS PERFORMED1. Assist with determining global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.2. Participates on various teams to define regulatory requirements of international submissions, Technical Files or regulatory rationales.3. Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.4. Prepares regulatory submissions to the COFEPRIS and other CCA Ministries of Health.5. Interacts with various levels of management, external agencies and companies.6. Assist with analysis and making recommendations regarding complaints received by Merit Medical; participates in complaint related meetings.7. Assist with developing, maintaining and analyzing department systems and provides training when needed.8. Participates in and assists with COFEPRIS inspections and other governmental inspections as directed.9. Performs other related duties and tasks, as required.ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS- Lifting - Not to exceed 50 lbs - local practice may apply.- Writing- Sitting- Standing- Bending- Visual acuity- Color perception- Depth perception- Reading- Field of vision/peripheralSUMMARY OF MINIMUM QUALIFICATIONS- Education and/or experience equivalent to a Bachelor's Degree in the biological, physical, engineering or material science disciplines and four years of related experience.- Knowledge of Mexico and CCA regulations, the Medical Devices Directive (93/42/EEC, as amended), and ISO 13485 Quality System Standards.- Supervisory skills are preferred.- Self-motivated, self-directing, strong attention to detail and excellent time management skills.- Strong interpersonal skills and the ability to communicate well - verbally and in writing - with others.- Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.COMPETENCIES- Regulatory submission/rationale preparation- Assistance with medical device and vigilance reporting- Computer skills/internet research- Interpersonal/communication skills- Assistance with regulatory system development/trainingCOMMENTSInfectious Control Risk Category III:The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.As an eligible Merit employee, you can expect the following:- Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights- Medical/Dental & Other Insurances (eligible the first of month after 30 days)- Low Cost Onsite Medical Clinic- Two (2) Onsite Cafeterias- Employee Garden | Gardening Classes- 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays- 401K | Health Savings AccountTo see more on our culture, go toMilitary Veterans are encouraged to Apply.Merit is a proud Utah Patriot Partner committed to hiring our Veterans.
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